Laryngeal mask airway device

ABSTRACT

A laryngeal-mask airway device including provision for drainage of the esophagus including an inflatable main-cuff and a backplate having a laryngeal-side and a pharyngeal-side. The backplate also has an external tube joint adjacent to the proximal region of the main-cuff. The backplate is hermetically bonded to the periphery of the main-cuff establishing separation between a laryngeal-chamber region and a pharyngeal region. A distally open evacuation tube includes a distal portion which longitudinally traverses the interior of the distal region of the main-cuff in sealed relation therewith for operative engagement and communication with the inlet of the oesophagus. The evacuation tube traverses the laryngeal-chamber region generally adjacent to the laryngeal-side of the backplate and passages through a proximally located tube-joint to the pharyngeal region. An airway tube also extends into the tube joint for communication with an airway port to provide a flowpath between the airway tube and laryngeal-chamber region.

CROSS-REFERENCE SECTION

This application is a continuation of currently U.S. patent applicationSer. No. 11/939,149, filed Nov. 13, 2007, which is a continuation ofSer. No. 11/350,470, filed Feb. 10, 2006, now U.S. Pat. No. 7,305,985,which is a continuation of U.S. patent application Ser. No. 10/225,678,filed Aug. 22, 2002, which is a continuation of U.S. patent applicationSer. No. 09/289,319, filed Apr. 9, 1999, now U.S. Pat. No. 6,439,232.This application also claims the benefit of United Kingdom patentapplication 9817537.5, filed Aug. 13, 1998.

BACKGROUND OF THE INVENTION

This invention relates to laryngeal mask airway devices (LMA-devices).Such devices are useful in facilitating lung ventilation in unconsciouspatients by forming a low pressure seal around the patient's laryngealinlet, avoiding the known harmful effects of the endotracheal tube,which forms a seal within the windpipe (trachea).

LMA-devices of the types disclosed in UK Patent Nos. 2111394 and 2205499have become accepted items of equipment for rapidly and reliablyestablishing an unobstructed airway in a patient in emergency situationsand in the administration of anaesthetic gases, and have found use inmost countries of the world. A disadvantage associated with the use ofsuch a mask is encountered in a patient who is at risk from vomiting orregurgitating stomach contents while unconscious since although thedevice forms a seal around the laryngeal inlet sufficient to permitartificial ventilation of the lungs, the seal is sometimes insufficientto prevent lung contamination during retching, vomiting orregurgitation.

A partial solution to this problem is disclosed in U.S. Pat. No.4,995,388 in which reliance is made upon a combination of an improvedperipheral continuity of seal pressure against the laryngeal inlet andthe provision of a drainage tube to conduct gastric contents away fromthe laryngeal inlet. However, one embodiment of such a system is itselfdisadvantaged by the fact that the removal of such gastric dischargescan be achieved only after the seal between the LMA device and thelaryngeal inlet/oesophagus has been breached. Another embodimentprovides for removal of gastric drainage without breaching the sealbetween the LMA device and laryngeal inlet/oesophagus, but this provedawkward to insert and caused throat irritation.

A more successful solution to this problem has been provided by thegastro-laryngeal mask airway device disclosed in U.S. Pat. No. 5,241,956and European Patent 651664. In that device, a drainage tube passesthrough the posterior aspect of the mask and through the distal end ofthe inflatable cuff of the mask to open in alignment with the patient'soesophagus. However, the drainage tube must be sufficiently rigid at itsdistal end to withstand the pressure within the inflated cuff and it hasbeen found that this may make proper insertion of the deflated deviceinto the patient's throat more difficult than either necessary ordesirable.

In a modified gastro-laryngeal mask airway device disclosed inInternational Patent Application WO 97/12680, provision is made for thedistal half of the mask to be of softly compliant construction, and toensure against collapse of the drainage tube when the cuff is inflated.Also, the mask has a flexible leading edge for facilitating correctinsertion into the throat of the patient.

European Patent Application 796631 and U.S. Pat. No. 5,632,271 disclosean LMA device which further facilitates insertion into the throat of thepatient, an LMA device includes a drainage tube, which opens into thedistal tip of the mask, passes along the posterior aspect of theflexible airway tube and emerges from the mouth of the patient justbelow the upper incisor teeth. For practical purposes this device workswell but has the following limitations.

A disadvantage of this back-to-back tube orientation is that it confersa degree of instability to the mask when the device is in place,permitting the possibility of loss of seal between the mask andlaryngeal inlet. Another disadvantage of the back-to-back tubeconfiguration is that it confers to the tubular elements of the devicean undesirable degree of stiffness so that movements of the head andneck of the patient occasioned, for example, by surgical manipulation orpositioning, may result in undue harmful pressure being exerted on thesurrounding tissues of the upper airway passages.

Another disadvantage is that the inserting index finger tends to slipoff the airway and drainage tube due to lack of purchase. A stillfurther disadvantage is that the inserting index finger may be damagedby the teeth of the patient because of the greater combined diameter ofthe back-to-back tubes.

SUMMARY OF THE INVENTION

The present invention has as its overall objective to provide an LMAdevice of the types described above, i.e., incorporating means fordraining gastric discharge from the region of the oesophageal inlet ofthe patient, which substantially avoids the disadvantages describedabove in relation to various of the known types of LMA-devices.

In accordance with the invention, this objective is achieved by firstmodifying the bowl of the mask such that its interior curvature has asignificantly deeper shape than previous constructions. This isaccomplished by either making the posterior wall or backplate of themask to generally the same peripheral dimensions to permit itsattachment to the posterior aspect of the inflatable cuff formation (incontrast to attachment to the inner rim or equator of the cuffformation), or by changing the cross section shape of the cuff so thatits seam is placed at offset from the major or equatorial plane. Hence,the backplate is located substantially behind, i.e., posteriorly of thecuff and not, as previously, within the annulus of the cuff. Thebackplate edge, or rim, is attached roughly tangentially with respect tothe roughly ring-shaped cross-section of the inflatable toroidal shapeof the cuff annulus. It will be evident that with this construction, thedepth of the bowl of the mask, i.e., the distance between the anterioraspect of the cuff when inflated and the anterior aspect of thebackplate, will be greater than in previous constructions byapproximately half the posterior-anterior dimension of the inflatedcuff. Since most adult-size LMA devices have cuff inflation diameters inthe range of 12 to 16 millimeters, it is clear that the additional bowldepth will be of the order of 6 to 8 millimeters. This additional bowldepth permits the gastric drain tube to be on the anterior surface ofthe backplate instead of running posteriorly as in previous designs,increasing the stability of the mask when installed in the throat of thepatient and reducing the tendency of the installed device to migrateoutwardly.

This anterior placement of the drain tube also eliminates therequirement to guard the aperture of the airway tube against obstructionby the anatomical structure known as the epiglottis. To prevent suchobstruction, former cuffs were provided with paired parallel barsrunning across the airway aperture. These bars proved effective inpreventing epiglottis obstruction but offered unwanted resistance toairflow and tended to obstruct passage of suction or inspection tubing.Anterior positioning of the drain tube allows it to act as an epiglotticprop, holding back the epiglottic rim from the floor of the mask and theairway port. The paired bars described above were not able to preventobstruction occurring as a result of the epiglottic rim lying in contactwith the bowl or floor of the mask. The anterior location of the draintube in the present invention overcomes the problems of epiglotticmisplacement more effectively than the previous design.

The second modification to the backplate is to replace the single tubejoint port adapted to accept the flexible airway tube with adouble-barrelled port in which said ports are arranged side-by-side,that is to say laterally, permitting easy assembly of said side-by-sideairway and drainage tubes. This provides better correspondence with thecross section space within the throat, the major axis of which runslaterally, and reduces stiffness and consequent pressure on the throatfrom movements of the head and neck of the patient. Also, theside-by-side adjacency reduces the pressure exerted on the drainage tubeby the incisor teeth of the patient, and facilitates manufacturing sincethe portions of the tubes in the throat of the patient describe similarradii.

The double-barrelled tube joint additionally provides a desirablelocating point for the tip of the index finger used to insert thedevice, thus reducing possible slipping of the finger on the tube-joint.Also, the reduced transverse diameter in the vertical direction betweenthe teeth of the patient resulting from the side-by-side adjacency ofthe drainage and airway tubes reduces possible injury to the finger fromcontact with the teeth.

A third modification to the backplate is the incorporation of a well ordepression covering an area of approximately 3 square centimeters andhaving a 2 to 5 millimeters depth situated in the anterior surface ofthe backplate under the drain tube where it connects with the distal endof the drain port of the backplate. The well has the dual functions ofpermitting gas circulation and allowing secretions from the trachea tobe drained away.

The LMA device of the invention is readily distinguished from thedevices proposed hitherto in which the backplate of the mask has beenlocated within the annulus of the inflatable cuff, and in which thegastric drainage tube has been routed across the posterior surface ofthe backplate.

According to the invention, therefore, there is provided a laryngealmask airway device equipped for drainage of gastric discharge, thedevice comprising an inflatable main-cuff and a backplate having alaryngeal-side and a pharyngeal-side. The backplate also has an externaltube joint adjacent to the proximal end of the main-cuff. The backplateis hermetically bonded to the periphery of the main-cuff establishingseparation between a laryngeal-chamber region and a pharyngeal region. Adistally open evacuation tube includes a distal portion whichlongitudinally traverses the interior of the distal region of themain-cuff in sealed relation therewith for operative engagement andcommunication with the inlet of the oesophagus. The evacuation tubetraverses the laryngeal-chamber region generally adjacent to thelaryngeal-side of the backplate and passages through a proximallylocated tube joint to the pharyngeal region. An airway tube also extendsinto the tube joint for communication with an airway port to provide aflowpath between the airway tube and laryngeal-chamber region.

These and other objects, features, and advantages of the invention willbe more fully understood from the following description of certainspecific embodiments of the invention taken together with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a simplified overall view to show an LMA-device of theinvention, installed in a patient whose relevant anatomical features areshown by phantom outlines;

FIG. 2 is a perspective view showing the LMA-device of FIG. 1 installedin a patient, the patient being shown in the quarter neck direction fromthe front right-side omitting most neck structures and showing asagittal section of the larynx, the epiglottis being shown displacedanteriorly relative to the main-cuff to show the internal-drain tube(normally, the epiglottis extends into the main-cuff), the right lateralportion and proximal region, including the hemispherical posteriorbulge, of the main-cuff being shown;

FIG. 3 is a plan view of the anterior side of the LMA-device of FIG. 1,the main-cuff being inflated and illustrated in enlarged scale relativeto FIG. 1, the airway and external-drain tubes being cut-off, the wellhidden behind the internal-drain tube also being shown;

FIG. 4 is an enlarged perspective view of a detail of FIG. 3 with theairway and evacuation tubes removed, showing the anterior surface of thetube joint and the posterior bulge of the main-cuff;

FIG. 5 is an enlarged plan view of a detail of FIG. 3 with the airwayand evacuation tubes removed, showing the anterior surface of the tubejoint and the posterior bulge of the main-cuff;

FIG. 6 is an enlarged end view of a detail of FIG. 3 with the airway andevacuation tubes removed, showing the proximal end surface of the tubejoint and the posterior bulge of the main-cuff;

FIG. 7 is a plan view of the posterior side of the device of FIG. 1, inthe same inflated condition as and to the scale of FIG. 3, the portionsof the airway tube and the external- and internal-drain tubes hidden inthe tube joint being shown, the well hidden behind the backplate alsobeing shown;

FIG. 8 is a lateral view in partial section, in the plane indicated bythe line 8-8 of FIG. 7 which is parallel to the sagittal plane and whichcoincides with the central longitudinal axis of the evacuation tube,except in the distal region of the main-cuff where the evacuation tubeis transversely offset from the sagittal plane, showing the longitudinaltraverse of the internal-drain tube along the backplate;

FIG. 9 is a view corresponding to FIG. 8 with portions broken away toshow the anterior-posterior dimension of the internal-drain tuberelative to a plane containing the anterior surface of the main-cuff;

FIG. 10 is a sectional plan view in the plane indicated by the line10-10 of FIG. 9 showing the location of the anterior-posterior dimensionof FIG. 9 relative to the proximal region of the main-cuff;

FIG. 11 is a distal view in cross section, in the plane indicated by theline 11-11 of FIG. 7 showing the engagement between the internal-draintube and backplate, and the adjacency between the seam in the main-cuffand backplate;

FIG. 12 is a distal view in cross-section of a second embodiment of thebackplate and back-cuff in a plane corresponding to the plane indicatedby line 11-11 of FIG. 7, showing a reduced wall thickness of thebackplate in the sagittal plane, and the back-cuff tethered to thebackplate;

FIG. 13 is a distal view in cross section, in the plane indicated by theline 13-13 of FIG. 7 showing a portion of the LMA-device between lines11-11 and 13-13, the clearance between the internal-drain tube and baseof the well being illustrated;

FIG. 14 is an enlarged fragmentary view of a detail of FIG. 8 showingthe connection between the external-drain tube and distal region of themain-cuff, the angles between selected parts and respective referenceplanes also being shown;

FIG. 15 is an enlarged fragmentary view of a detail of FIG. 8 showingthe connection between the internal and external-drain tubes;

FIG. 16 is an anterior perspective view of the backplate removed fromthe LMA-device of FIGS. 3 and 7;

FIG. 17 is a perspective view, in the aspect indicated by line 17 ofFIG. 16, showing the recessed heel portion and well, and also showingthe double-barrelled passage for the connections of the airway andexternal-drain tubes;

FIG. 18 is an anterior view of a second embodiment of the backplate ofFIG. 16;

FIG. 19 is a perspective view of the second embodiment of the backplateillustrated in FIG. 18, in the aspect indicated by line 20, showing therecessed heel portion, and the double-barrelled passage for theconnections for the airway and external-drain tubes;

FIG. 20 is a perspective view of the anterior surface of the LMA-deviceof FIGS. 3 and 7 in a deflated condition;

FIG. 21 is a lateral view of the main-cuff in the direction indicated byline 22 of FIG. 20 showing the preferred deflection characteristic ofthe main-cuff;

FIG. 22 is a perspective view in the aspect of FIG. 20 showing theLMA-device of FIGS. 3 and 7 in an inflated condition;

FIG. 23 is a plan view of the anterior side of a third embodiment of theLMA-device of FIGS. 3 and 7 showing one-way valves incorporated in theanterior wall of the main-cuff; and

FIG. 24 is a lateral view of the main-cuff of the embodiment illustratedin FIG. 23 in the direction indicated by line 23-23 showing one of theone-way valves and its associated housing.

Corresponding reference characters indicate corresponding partsthroughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, the anatomical terms “anterior” and “posterior”, withrespect to the human body, refer to locations nearer to the front of andto the back of the body, respectively, relative to other locations. Theterm “anterior-posterior (A-P)” refers to a direction, orientation orthe like pointing either anteriorly or posteriorly. The anatomical terms“proximal” and “distal”, with respect to applying an instrument to thehuman body, refer to locations nearer to the operator and to the insideof the body, respectively. Alternatively, “distal”, as opposed to“proximal”, means further away from a given point; in this case,“distal” is used to refer to positions on the LMA-device 20 or in thebody relative to the extreme outer or connector end of the LMA-device.“Proximal” is the opposite of “distal”. The term “lateral” refers to alocation to the right or left sides of the body, relative to otherlocations. Alternatively, “lateral” means to one or other side of themid-line, with respect to the major axis of the body, or to a devicelying in the body's major axis. The term “bilateral” refers to locationsboth to the left and right of the body, relative to the sagittal plane.The term “sagittal” or “sagittally” refers to a vertical longitudinalplane through the center or midline of the body that divides abilaterally symmetrical body into right and left halves. The sagittalplane is the plane passing antero-posteriorly through the middle of thebody in its major axis. The term “medial” means nearer to the mid-line.

A laryngeal-mask airway device (LMA-device) of the present invention, isdesignated generally by the reference numeral 20 in FIGS. 1 and 2. TheLMA-device 20, in a deflated condition, is inserted into the throat 32the upper surface of which is bounded by hard and soft palates 192, 195.The LMA-device 20 is lodged in the pharynx 197 of the throat 32 at thebase of the hypo-pharynx 212 where the throat divides into the trachea36 (i.e., windpipe) and oesophagus 57. A lower portion of the LMA-device20 reaches to the base of the hypo-pharynx 212. After the LMA-device 20is so lodged in the pharynx 197 such that the lower portion of theLMA-device reaches the base of the hypo-pharynx 212, the LMA-device isinflated. Disposed in the junction between the throat 32 and trachea 36is the flexible epiglottis 35 (i.e., a lid-shaped structure) which formsthe upper border of the larynx 37, entry through which is provided bythe laryngeal inlet 67. To facilitate understanding of the relationsbetween the LMA-device 20 and anatomy of the throat 32 and relatedstructures, a glossary of the anatomical structures related to theLMA-device is provided herein below.

Referring to FIGS. 1 and 2, the laryngeal-mask airway device(LMA-device) 20 is shown comprising an airway tube 22, installed throughthe mouth 25 of a patient. The LMA-device 20 further comprises abackplate 27 having an airway port 30 through which the airway tube 22can establish a free externally accessible ventilation passage, via thepatient's mouth 25 and throat 32, and past the epiglottis 35 to thelarynx 37. The backplate 27 is preferably of an elastomer such assilicone rubber and relatively stiff, for example, of 80 Shoredurometer.

As further shown in FIGS. 3 and 7, the backplate 27 is surrounded by amain-cuff 40 comprising an inflatable ring which, when inflated, has theshape of a torus generated by an asymmetrical oval or ellipse having awider proximal region 42 and narrower distal region 45. The main-cuff 40is circumferentially united to the backplate 27 in essentially a singleplane, except for the portion of the main-cuff extending into a recess47 in a heel 50 of the backplate 27. The portion of the main-cuff 40extending into the recess 47 may or may not be united to the backplate27, as described further hereinbelow.

The main-cuff 40 may also be of silicone rubber, although preferablyrelatively soft and flexible compared to the backplate 27. The materialof the main-cuff 40 is preferably of 20 to 30 Shore durometer. Exceptfor a plastic connector (not shown) attached to the proximal end of theairway tube 22 and a check valve 52, all parts of the LMA-device 20disclosed herein are preferably made of silicone, possibly withdifferent additives.

An externally accessible tube 55 and inflation port 56 on the main-cuff40 are the means of supplying air to the main-cuff and of extracting airfrom (and therefore collapsing) the main-cuff for purposes of insertionin or removal from the patient. The check-valve 52 is disposed in thetube 55 for holding a given inflation or holding a given deflation ofthe main-cuff 40.

In the installed position of FIGS. 1 and 2, the projecting but blunteddistal region 45 of the main-cuff 40 is shaped to conform with the baseof the hypo-pharynx 212 where it has established limited entry into theupper sphincteral region of the oesophagus 57. The pharyngeal-side 60 ofthe backplate 27 is covered by a thin flexible panel 62, as shown inFIGS. 7, 11 and 13, which is peripherally bonded to a margin 63 on theposterior surface of the main-cuff 40, to define an inflatable back-cuff65 comprising a cushion which assures referencing to the posterior wallof the pharynx and thus is able to load the inflated main-cuff forwardfor enhanced effectiveness of sealing engagement to the inlet 67 of thelarynx 37. The inflated main-cuff 40, thus-engaged to the laryngealinlet 67, orients a distal-end 72 of the airway tube 22 at an acuteangle to a mid-line major plane 75 of the main-cuff 40 and insubstantial alignment with the axis of the laryngeal inlet 67, fordirect airway communication only with the larynx 37.

The major plane 75 is a plane containing the major axis 77 of main-cuff40 extending between proximal and distal regions 42, 45. The major plane75 is disposed between, and parallel to, the anterior and posteriorsurfaces of the main-cuff 40. Additionally, the major plane 75 isequidistant from the anterior and posterior surfaces of the main-cuff40, except for posterior bulge 100.

The LMA-device 20 is of the GLM (gastro-laryngeal mask) variety in whichan evacuation tube, designated generally by 80, as shown in FIGS. 1, 2,3 and 7, serves for extraction and external removal of gastric-dischargeproducts from the oesophagus 57. Additionally, the evacuation tube 80provides a pathway into the oesophagus 57 for insertion, for example, ofa gastric feeding tube, suction catheter, temperature probe or othermonitoring device, probes carrying stimulating electrodes such as pacingwires, sengstaken balloons, or other catheters bearing inflatable cuffs,fiber optic endoscopes or medication. The evacuation tube 80 follows thegeneral course of the airway tube 22, with sealed entry through thebackplate 27 alongside the airway tube, on the laryngeal-side 81 of thebackplate, and with sealed passage through the interior of the main-cuff40 and open through the distal region 45 of the main-cuff. Inflation-airsupply to the back-cuff 65 may be via the same tube 55 as for themain-cuff 40, or separate inflating means (not shown) may be providedfor the back-cuff 65. The disclosures of U.S. Pat. Nos. 5,241,956, and5,632,271, and 5,878,745 disclosing various laryngeal mask devices, arehereby incorporated by reference herein.

More specifically, the toroidal-shaped main-cuff 40 is formed by firstmoulding it in an intermediate stage having opposing edges, each ofwhich has an elliptical shape. The opposing edges of the main-cuff 40,when in generally edge-to-edge relation, are welded together to form aseam 85, as shown in FIGS. 5, 11 and 13. The seam 85 defines an ovalcontained in a plane which is parallel to the major plane 75,corresponding to the internal surface of the main-cuff 40. When thebackplate 27 is attached to the main-cuff 40, the seam 85 abuts theperiphery of the oval portion 87 in anterior relation to the backplate,as best shown in FIGS. 11 and 13. The seam 85 may be inserted in acorresponding groove in the oval portion 87. Alternatively, thebackplate 27 and main-cuff 40 may be extruded as a single, unitarypiece.

As used herein, the term “welding” describes the bonding together of twocomponents having the same or similar chemical compositions, either byadhesive having the same or similar chemical composition as thecomponents, or by high pressure or temperature fusion, or a combinationof any of them.

A separate tube (not shown), preferably with multiple perforations alongits length, may be contained within the main-cuff 40 between the openingof the tube 55 into the main-cuff such that each perforationcommunicates with a port between the interiors of the main-cuff andback-cuff 65. Such a separate tube preserves a flowpath between the tube55 and back-cuff 65 if the main-cuff 40 is completely collapsed fromdeflation, thereby providing for further deflation of the back-cuff 65via the tube 55. Alternatively, a channel (not shown) may be formed onthe inner surface of the main-cuff 40 between the opening of the tube 55into the main-cuff and at least one of the one or more ports between theinteriors of the main-cuff and back-cuff 65. Such a channel preserves aflowpath between the tube 55 and back-cuff 65 if the main-cuff 40 iscompletely collapsed from deflation.

The backplate 27 has a one-piece, integral spoon-shape which, with theoval portion 87, also has an external tube joint 92. The tube joint 92is oriented proximally relative to the oval portion 87. Opposite sidesof the oval portion 87 are defined by a convex pharyngeal-side 60 andconcave laryngeal-side 81. The periphery of the oval portion 87 ishermetically bonded to the periphery of the main-cuff 40 to establishseparation between the laryngeal-chamber region 110 and pharyngealregion 112.

The periphery of the oval portion 87 of the backplate 27 abuts, inproximal relation to, the seam 85 of the main-cuff 40 in its inflatedcondition, as shown in FIGS. 10 and 12. This more posterior location ofthe backplate 27, as compared to locating the periphery of the ovalportion 87 in the major plane 75, provides additional space for theinternal-drain tube 115. The oval portion 87 may be located at variouspositions in the anterior-posterior direction relative to the main-cuff40 because of the generally constant cross-section of thelaryngeal-chamber region 110 in planes parallel to major plane 75, asshown in FIGS. 10 and 12.

Formed in the laryngeal-side 81 is a well 95 defined by a depressionadjacent to the tube joint 92. The well 95 faces the evacuation tube 80such that the well is offset relative to the sagittal plane 97 of themain-cuff 40. The well 95 thereby provides a radial clearance betweenthe evacuation tube 80 and laryngeal-side 81.

The portions of the laryngeal-side 81 which are proximal and distal ofthe well 95 are inclined relative to the base of the well such that thelaryngeal-side ramps anteriorly as it approaches the well in the distaland proximal directions, as shown in FIG. 8.

The periphery of the oval portion 87 adjacent to the tube joint 92 isincluded in the heel 50. A portion of the heel 50 contiguous with itsanterior edge is removed to define a crescent-shaped recess 47. Theproximal region 42 of the main-cuff 40 has an approximatelyhemispherical posterior bulge 100 arising from its posterior surface, asshown in FIG. 8. The posterior bulge 100 extends posterioritysymmetrically relative to the sagittal plane 97 to fit into the mid-linegroove 102 forming part of the anterior surface of the double-barrelledtube joint 92 of the backplate 27. The mid-line groove 102 is shown inFIG. 16. The posterior bulge 100 also extends into the crescent-shapedrecess 47 to compensate for the reduced support provided by thebackplate 27 resulting from the recess 47.

Less than the entire width of the main-cuff 40 extends posteriorly fromthe proximal region 42 because the recess 47 of the backplate 27 allowsspace for the main-cuff 40 to extend posteriorly in the approximatelyhemispherical posterior bulge 100. The posterior bulge 100 is partiallysupported bilaterally by the backplate 27 thus preventing ballooning-outof this portion of the main-cuff 40. Such ballooning-out of themain-cuff 40 would result in the flow of internal gases from otherinterior regions of the main-cuff resulting from redistribution of thepressure in the main-cuff, thereby resulting in an uneven seal betweenthe main-cuff and the tissues surrounding the laryngeal inlet 67. Suchan uneven seal might result in loss of seal, particularly at the pointeddistal end of the main-cuff 40.

The recess 47 and mid-line groove 102 together form a partial socketwhich provides mechanical support posteriority, bilaterally and distallyfor the posterior bulge 100.

The posterior bulge 100 may be separable from the recess 47 to define anormally closed and therefore self-sealing port for insertion of anelongate member such as a probe, endotracheal tube, endoscope or thelike from the pharyngeal-region 112 into the laryngeal-chamber region110. This enables such-an elongate member to be inserted into thelaryngeal-chamber region 110 without occupying the interior of theairway tube 22 which may obstruct air flow through the airway tube.Additionally, throughout insertion of such an elongate member throughthe port and the laryngeal-chamber region 110, the elongate member isanterior of the internal-drain tube 115.

In comparison, if such an elongate member is inserted through the airwayport 30 into the laryngeal-chamber region 110, upon entry into thelaryngeal-chamber region, the distal end of the elongate member liessubstantially parallel to the internal-drain tube 115. Accordingly,shortly after entry into the laryngeal-chamber region 110, uponcontinued insertion into the laryngeal-chamber region, the insertiondirection of such an elongate member must normally be sharply changed toenable entry into or viewing of the larynx 37 or bronchial tree.Additionally, insertion of such an elongate member through the airwayport 30 into the laryngeal-chamber region 110 results in the elongatemember being laterally offset from the sagittal plane 97 since theairway port is so offset from the sagittal plane. Such an elongatemember must therefore be suitably steered if it is to be aligned in thesagittal plane 97. Aligning such an elongate member in the sagittalplane 97 may facilitate its further insertion through the larynx 37 intothe trachea.

The elongate tube joint 92 is formed on the pharyngeal-side 60 andextends posteriorly and proximally relative to the oval portion 87. Thetube joint 92 includes a longitudinal passageway 105 extending from itsproximal end 107 distally to the concave laryngeal-side 81. Thepassageway 105 has a double-barrelled cross section for supporting theairway tube 22 and evacuation tube 80, described more fully hereinbelow. The longitudinal central axis of the passageway 105 is containedin the sagittal plane 97 and inclined posteriority at an angle ofapproximately 30 degrees relative to the major plane 75, as viewed inthe sagittal plane 97.

A strap 200 is moulded to the external anterior surface of the proximaltube joint 92 in arching relation over the mid-line groove 102. Themoulding of the strap 200 onto the anterior surface of the proximalportion of the tube joint 92 defines an introducer tool slot 201. Thedistal edge of the strap 200 has an internal curved edge 203 againstwhich abuts the posterior bulge 100 (which is an extension of the maincuff 40), as shown in FIGS. 4, 6 and 16. The introducer tool slot 201and curved edge 203 avoid becoming dirt trap because when the main-cuff40 is deflated, the posterior bulge 100 (i.e, the main-cuff extension)pulls away from the strap 200, thus avoiding the formation of a blindpocket which could be a dirt trap.

FIGS. 18 and 19 show a second embodiment of the backplate 27 b. Parts inFIGS. 18 and 19 having corresponding parts in FIGS. 16 and 17 have thesame reference numeral with the addition of suffix b. The backplate 27 bis similar to the backplate 27 illustrated in FIGS. 16 and 17 exceptthat the backplate 27 b does not a strap similar to strap 100.

The evacuation tube 80 comprises an internal-drain tube 115 extendingbetween the tube joint 92 and the distal region 45 of the main-cuff 40on the laryngeal-side 81 of the backplate 27. The internal-drain tube115 longitudinally traverses the interior of the distal region 45 of themain-cuff 40 in sealed relation therewith for operative engagement andcommunication with the inlet of the oesophagus 57. The internal-draintube 115 is anterior relative to the seam 85 of the main-cuff 40 suchthat the seam is disposed between the internal-drain tube and the distalend of the oval portion 87.

The internal-drain tube 115 therefore pierces the distal region 45 atthe proximal crotch-region 117 and the longitudinally opposing distalcrotch-region 120, both of which are portions of the distal region 45.The edges of the main-cuff 40 in the crotch-regions 117, 120 surroundingthe internal-drain tube 115 are hermetically sealed to the tube suchthat the enclosure of the main-cuff 40 is defined in part by theexternal cylindrical surface of the internal-drain tube.

The internal-drain tube 115 terminates in an oblique distal orifice 123opening out on the anterior distal aspect of the distal region 45 of themain-cuff 40. The oblique distal orifice 123 results in partialflattening of the distal region 45 such that the flattening is in atransverse plane inclined relative to the major plane 75 by an angle aof preferably approximately 45 to 50 degrees when main-cuff 40 isinflated, as shown in FIG. 14. When the main-cuff 40 is deflated, anglea is preferably approximately 40 to 45 degrees. In adult sizes of theLMA-device 20, the surface area of the distal region 45 removed toaccommodate the orifice 123 is approximately 1 square centimeter whichis therefore no longer available to contribute to expansion of themain-cuff 40 when the main-cuff is inflated for sealing around thelaryngeal inlet 67. Accordingly, to prevent inspired gas leakage acrossthe distal region 45 resulting from insufficient local expansion of themain-cuff 40, additional circumferential area of the anterior surface ofthe distal region may be required for sealing. This may be provided byinversion of the anterior-facing lip 127 of the distal region 45surrounding the orifice 123 resulting from longitudinal withdrawal ofthe intra-cuff portion 130 of internal-drain tube 115 approximately 3.5millimeters relative to the plane containing the distal end of thedistal region 45 of the main-cuff 40. This inversion produces acorresponding lateral bulging of the distal region 45 around the orifice123. The anterior position of the distal orifice 123 ensures lesscompressive force resulting from the fluid pressure inside the main-cuff40 on the intra-cuff portion 130 in the anterior-posterior direction,thus compensating for anterior-posterior compression from anatomicalstructures in the throat 32 so that the internal-drain tube 115 issubject to approximately equal compressive forces laterally andanterior-posteriorly, hence avoiding collapse.

The part of the intra-cuff portion 130 containing the distal orifice 123has a longitudinal central axis inclined relative to the planecontaining the distal orifice by an angle .gamma. of preferably 60degrees, and inclined relative to the major plane 75 by an angle Δofpreferably 20 degrees. The longitudinal central axis of the intra-cuffportion 130 is contained in the sagittal plane 97.

The distal orifice 123 has diametrically opposed posterior and anteriorapexes 135, 137. The distal orifice 123 is contained in a transverseelliptical plane preferably inclined by an angle β, which is preferably40 degrees, relative to the major plane 75, as shown in FIG. 14. Theinclination of the distal orifice 123 is such that the posterior apex135 is offset distally relative to the anterior apex 137 along thelongitudinal axis of the portion of the internal-drain tube 115containing the distal orifice 123.

Integral with the external anterior surface of the intra-cuff portion130 adjacent to the distal orifice 123 is a semicircular transverseshoulder 142, as shown in FIG. 9. The anterior and the adjacent lateralportions of the distal edge of the distal region 45 of the main-cuff 40are bonded to the proximal surface of the shoulder 142. The posteriorand remaining lateral portions of the distal edge of the distal region45 are bonded to the unshouldered external surface adjacent to thedistal orifice 123.

The lateral termination of each end of the shoulder 142 facilitatescollapse of the distal orifice 123 in the major plane 75 when themain-cuff 40 is deflated since the un-reinforced posterior portion ofthe intra-cuff portion 130 is able to collapse more readily when thepressure inside the main-cuff 40 is reduced (i.e., negative pressure isapplied to the main-cuff). Also, by limiting the circumferentialdimension of the shoulder 142, its peripheral length which must bedeflected is reduced. In contrast, if the shoulder 142 extendedposteriorly a sufficient amount such that it traversed the major plane75, the portions of the shoulder that traversed the major plane wouldrequire closure to close distal orifice upon deflation of the main-cuff40. Such closure of such a shoulder would require significantly moreforce than required to flatten the shoulder 142, shown in FIG. 14. Suchincreased force may require stronger material for the main-cuff 40 andapplication of higher deflation vacuums to the main-cuff.

The distal orifice 123 is withdrawn proximally relative to the distalregion 45 of the main-cuff 40 resulting in the portion of the distalregion 45 adjacent to the distal orifice 123 being invaginated when themain-cuff 40 is inflated, as shown in FIG. 14. The bonding of the distalend of the distal region 45 to the distal surface of the shoulder 142results in the transversely-arcuate inverted anterior-facing lip 127 ofthe invaginated surface having the greatest radial bulge. Thetransversely-arcuate lateral portions 145, 147 of the invaginatedsurface have the next largest radial bulge with the transversely-arcuateposterior portion 150 having the least radial bulge. The opposed lateralportions 145, 147 are symmetrical about the sagittal plane 97 of themain-cuff 40.

The portion of the internal-drain tube 115 longitudinally traversing theinterior of the distal region 45 of the main-cuff 40 defines intra-cuffportion 130. The outer surface of the intra-cuff portion 130 has atleast one circumferential strengthening rib 152 proximal of the shoulder142 to resist radial collapse of the intra-cuff portion 130 byinternally directed radial forces resulting from the fluid pressurewithin the main-cuff 40. The rib 152 is contained in a transverseelliptical plane preferably inclined at an angle θ, preferably of 60degrees and equal to angle γ, relative to the longitudinal axis of theintra-cuff portion 130, as shown in FIG. 14. The inclination of the rib152 enables its posterior pivoting about its posterior apex duringdeflation of the distal region 45 to facilitate flattening of themain-cuff 40.

The portion of the internal-drain tube 115 proximal of the intra-cuffportion 130 is laterally offset from the sagittal plane 97, as shown inFIGS. 3 and 7. The portion of the internal-drain tube 115 where itemerges from the proximal crotch-region 117 and extends to the well 95is received in a groove 157 formed in the oval portion 87, as shown inFIG. 7. The groove 157 is defined laterally by fillets 160 whichlaterally abut the internal-drain tube 115. As much as 50% of theposterior portion of the cross-sectional area of the internal-drain tube115 may be contained in the distal portion of the groove 157, exceptwhere its circumference is free posteriority, i.e., where it runs overthe well 95. In one size of the main-cuff 40, the longitudinal dimensionof the groove 157 is 2.5 centimeters. The internal-drain tube 115 iswelded to the groove 157.

The fillets 160 resist anterior deflection of the oval portion 87 sincethe fillets provide increased surface area for the weld between theinternal-drain tube 115 and oval portion. This additional resistancecompensates for the reduced resistance resulting from a reduction in theanterior-posterior thickness of the part of the oval portion 87 definingthe base of the groove 157. Such reduced anterior-posterior thickness isdesirable to increase the anterior-posterior dimension a between theanterior surface of the main-cuff 40, and the portion of theinternal-drain tube 115 between the proximal crotch region 117 and well95, shown in FIG. 8, especially at the location of dimension b, shown inFIGS. 9 and 10, which should have a depth of at least 10 millimeters inadult sizes, described further herein below.

FIG. 12 illustrates a second embodiment of the LMA-device 20 a in whichthe flexible panel 62 a is tethered to the backplate 27 a. The parts inFIG. 12 having corresponding parts in FIGS. 1 to 11 have the samereference numeral with the addition of suffix a. Tethering of the panel62 a to the backplate 27 a provides additional resistance to anteriorinversion of the oval portion 87 a. This enables further reduction inthe anterior-posterior thickness of the part of the oval portion 87 adefining the base of the groove 157 a. As discussed above, such reducedanterior-posterior thickness is desirable to increase theanterior-posterior dimension, corresponding to the dimension a in FIG.8.

A longitudinal portion of the internal-drain tube 115 extends over well95, as shown in FIG. 8. The anterior-inclination of the portions of thelaryngeal-side 81 proximal and distal of the well 95, described hereinabove, anteriorly props the portion of the internal-drain tube 115extending over the well to increase the anterior-posterior clearancebetween the internal-drain tube and base of the well. The internal-draintube 115 arches over the well 95 defining a slight posterior curve andsimultaneously curving laterally to its insertion in the tube joint 92.

The evacuation tube 80 includes an external-drain tube 165 having adistal end 167 connected in end-to-end relation to the proximal end 170of the internal drain-tube 115. The joint between the internal andexternal-drain tubes 115, 165 is located where the tube joint 92 opensinto laryngeal-chamber region 110, as shown in FIGS. 8 and 15.

The inner diameters of the internal-drain tube 115 and external-draintube 165 are the same. The outer diameter of the internal-drain tube 115is less than the outer diameter of the external-drain tube 165. Thedistal end 167 of the external-drain tube 165 has an internalcountersunk portion 172 defined by a bevelled internal axial wall, asshown in FIG. 15. The outer diameter of the countersunk portion 172 isgreater than the outer diameter of the internal-drain tube 115. Theproximal end 170 of the internal-drain tube 115 abuts the countersunkportion 172 resulting in coaxial self-alignment of the centrallongitudinal axes of the distal and proximal ends 167, 170.

As shown in FIGS. 8 and 15, the external-drain tube 165 is supported inthe cylindrical drain barrel 175 of the double-barrelled passageway 105which is longitudinally offset from the well 95 at an angle ofapproximately 9 degrees. The internal-drain tube 115 is thereby disposedanteriorly of the well 95 and is also offset at 9 degrees from the majoraxis of drain barrel 175 to increase the lateral clearance.

The evacuation tube 80 is preferably moulded to the backplate 27.Alternatively, for making a prototype, assembly of the evacuation tube80 to the backplate 27 may be by first welding the distal portion of theinternal-drain tube 115 into the distal region 45 of the main-cuff 40.Before connecting the proximal end of the internal-drain tube 115 totube joint 92, the main-cuff 40 is welded to the backplate 27. Theexternal-drain tube 165 is then welded into the drain barrel 162 of thetube joint 92, for example, by an adhesive 173. Hardening of these weldseffectively clamps and fixes the distance between the distal end of theproximal crotch-region 117 of the main-cuff 40 and the distal end 167 ofthe external-drain tube 165. The internal-drain tube 115 is cut, asneeded, such that it is slightly longer than this distance. The proximalend 170 of the internal-drain tube 115 is then inserted into thecountersunk portion 172 of the external-drain tube 165 with thecountersunk portion resulting in coaxial self-alignment of thelongitudinal central axes of the distal and proximal ends 167, 170. Theinternal-drain tube 115 is then welded to the tube joint 92, forexample, by an adhesive 174.

The slightly longer length of the internal-drain tube 115 relative tothe distance between the proximal crotch-region 117 and distal end 167results in a slight longitudinal compression of the internal-drain tubecausing lateral curvature of it away from the adjacent side-wall 177 ofthe backplate 27. Lateral curvature of the internal-drain tube 115 awayfrom the adjacent side-wall 177 increases the lateral clearance betweenthem, reducing the likelihood of dirt collecting between them.

As shown in FIGS. 3 and 7, the airway tube 22 is supported in thecylindrical airway barrel 180 of the double-barrelled passageway 105 incommunication with the airway port 30 defined by the opening of theairway barrel 180 into the laryngeal-side 81. Such communicationprovides a flowpath between the airway tube 22 and laryngeal-chamberregion 110. The airway tube 22 is connected to the tube joint 92 bywelding using an adhesive or, alternatively, connected by high-pressureor temperature fusion.

The airway tube 22 and external-drain tube 165 are welded together inside-by-side tangential relation, as shown in FIG. 2. The welding isaccomplished by depositing adhesive in one or both of the crevicesdefined by the outer surfaces of the tubes 22, 165 adjoining the line oftangential contact between them. The adhesive preferably extendslongitudinally from the tube-joint 92 proximally for approximately 4¼inches. Alternatively, the tubes 22, 165 may be connected together byhigh pressure or temperature fusion. Also, the tubes 22, 165 may bemanufactured by simultaneous extrusion. Additionally, the tubes 22, 165may remain separate for certain clinical applications, e.g., operationson the tongue 202 in the mid-line or other mid-line structures in thepharynx 197.

The airway tube 22 and external-drain tube 165 are inserted through abite-plate 176 comprising a sleeve which is telescopically fitted aroundthe tubes 165, 176, as shown in FIG. 2. The bite-plate 176 is positionedlongitudinally on the tubes 22, 165 such that, when the LMA-device 20 iscompletely inserted into the throat 32 and pharynx 197, the bite-plateis positioned between the upper and lower teeth, described furtherherein below.

In embodiments in which the airway tube 22 is bonded to theexternal-drain tube 165, the tubes 22, 165 are bent away from oneanother, laterally at the proximal extent of the adhesive to facilitaterouting of the airway tube to a ventilating apparatus (not shown) andthe external-drain tube 165 to a suction-apparatus (not shown), ifrequired. The separation of the airway tube 22 and external-drain tube165 is achieved by placing a sleeve 182 on the airway tube to cover theproximal 3 centimeters of the airway tube. The sleeve 182 is proximallyoriented relative to the bite-plate 176. Connected to the distal end ofthe sleeve 182 is a triangular wedge 185 oriented toward theexternal-drain tube 165 to force the softer external-drain tube toincline away from the airway tube 22 by an angle C, preferablyapproximately 15 degrees. The sleeve 182 and wedge 185 are a singlemoulding and are welded to the airway tube 22. Additionally, the wedge185 is welded to the external-drain tube 165. The sleeve 182 alsostiffens the proximal end of the airway tube 22 to reduce the likelihoodof kinking at its attachment to the ventilating apparatus (not shown).

The portions of the airway tube 22 and external-drain tube 165 inside-by-side tangential relation each have the same outer diameter. Theinner diameter of this portion of the airway tube 22 is greater than theinner diameter of the adjoining portion of the external-drain tube 165.These portions of the airway tube 22 and external-drain tube 165 eachhave approximately the same stiffness and resistance to longitudinalbending. A metallic cylindrically helical wire 190 is provided betweeninner and outer surfaces of the airway tube 22 in coaxial relationtherewith to increase the kink resistance of the thinner-wall airwaytube. The kink resistance of this portion of the airway tube 22 may befurther increased by forming it of a material having a harder durometerof silicone. It may also be possible for the chemical compositions ofthese portions of the tubes 22, 165 to be approximately the same if, forexample, the helical wire 190 sufficiently increases the stiffness ofairway tube.

A hard plastic or polycarbonate cylindrical fitting (not shown) isinserted in the end of the airway tube 22 proximal of the triangularwedge 185. The fitting is inserted into the airway tube 22, and has aradial flange which abuts the proximal end of the airway tube tolongitudinally limit the insertion of the fitting into the airway tube.The fitting facilitates connection to the ventilating apparatus (notshown).

In use, an inflation/deflation device is actuated to apply a vacuum, viathe tube 55, to the main-cuff 40 sufficient to fully deflate it prior toinsertion of the main-cuff through the mouth of the patient. Such avacuum extends to the space enclosed by the flexible panel 62 andbackplate 27, via the channel 90 in the main-cuff 40, deflating theback-cuff 65 to collapse it onto the pharyngeal-side 60 of the backplate27 and posterior surface of the main-cuff.

The main-cuff 40 is preferably deflated into a predetermined shape byusing the forming tool disclosed in U.S. Pat. No. 5,711,293, the entiredisclosure of which is hereby incorporated by reference herein.

The flattened sheet, comprising fully deflated the main-cuff 40,backplate 27 and internal-drain tube 115, is passed easily through themouth 25 of the patient because of the reduced compressibleantero-posterior dimension of the part of the LMA-device 20 having thelargest anterior-posterior dimension, i.e., the generally proximalregion 42 of the main-cuff 40 and the heel 50. This reduced compressibleantero-posterior dimension results from the recess 47 of the heel 50.The deflated main-cuff 40, backplate 27 and internal-drain tube 115 ispressed against the hard and soft palates 192, 195 as it is pushedinwardly, resulting in the deflated main-cuff being guided distally bythe soft palate onto the posterior wall of the pharynx 197. Suchdeflection of the main-cuff 40 is normally only reliably achieved if thetotal stiffness of the LMA-device 20 is within certain predeterminedlimits.

The main-cuff 40 is preferably urged through the throat 32 by placementof either the operator's index finger or an insertion tool inserted intothe strap 200 against the heel 50, because the side-by-side airway tube22 and internal-drain tube 115 are normally not sufficiently stiff to beused as a rod to direct the main-cuff through the throat.

The main-cuff 40 is preferably positioned in the throat 32 by insertingthe a sufficient length of the index finger of the operator through theintroducer tool slot 201 such that the finger is placed on the mid-linegroove 102 of the tube joint 92 and the end of the finger abuts the heel50, as shown in FIG. 16. Inserting the finger through the introducertool slot 201 enables the finger to be partly wedged into the strap 100to secure the index finger to the mid-line groove 102. Placement of theindex finger on the mid-line groove 102 of the tube joint 92 and againstthe heel 50 assists in locating and stabilizing the finger against theproximal region 42 of the main-cuff 40. This reduces the risk of fingerslippage from its intended position on the backplate 27 due to thepresence of slippery secretions in the mouth 25 and/or the applicationof lubricant, to assist smooth passage of the LMA-device 20 during itsinsertion into the patient and to avoid the risk of injury to thepatient or of damage to the LMA-device. During such insertion, theproximal region 42 of the main-cuff 40 provides a fulcrum.

An alternative and equally preferable way to position the main-cuff 40in the throat 32 is by an introducer tool (not shown) including arelatively rigid elongate member having a distal end adapted forremovable keyed engagement with the heel 50 and strap 200 adjacent tothe tube joint 92 for insertional guidance of the main-cuff 40. Duringsuch insertion, as with placement of the operator's finger against theheel 50, the proximal region 42 of the main-cuff 40 provides a fulcrum.The introducer tool and LMA-device 20 may both be included in a kit.

Preferably, the deflated main-cuff 40 and backplate 27 are sufficientlyflexible that they do not overcome the resistance provided by the softpalate 195. The main-cuff 40 and backplate 27 are preferably flexiblesimilar to a palette knife such that, when the main-cuff and backplateare urged or tensed against the soft palate 195, the distal region 45 isdeflected downward by the soft palate rather than being forcibly driveninto it, which may bruise the soft palate. Also preferable is for thedeflated main-cuff 40 to itself bend smoothly around (i.e., in the shapeof) an arc 196, as shown in FIG. 21, also similar to a palette knife.

Further, the deflated main-cuff 40 and backplate 27 resist kinking.Kinking results in the main-cuff 40 and backplate 27, during theirinsertion through the throat 32, collapsing on the tongue 202 ratherthan arching over it. To avoid kinking, a specific overall stiffness andlong-axis gradation of stiffness in the delated main-cuff 40 isrequired, which in turn depends on the shape of the backplate 27. Theprimary factors or considerations to be balanced when designing thebackplate 27 are (i) desirability of long-axis gradation of stiffness(i.e., linear tapering-off distally of resistance to flexure), (ii)adequate stiffness and appropriate architecture to prevent anteriorherniation from fluid pressure within the inflated back-cuff 65, and(iii) minimal thickness in the anterior-posterior dimension to reduceoverall resistance to flexure.

The relative stiffness of the airway tube 22, external-drain tube 165and backplate 27 facilitate piloting and guiding of the substantiallyflattened, deflated main-cuff 40 to smoothly ride or track posteriorcontours of the throat 32 and pharynx 197 and to assure that thedeflated main-cuff enters and locates immediately above the upperoesophageal sphincter 207 and adjacent to the laryngeal inlet 67, asshown in FIGS. 1 and 2.

Additionally, the backplate 27, internal-drain tube 115 and main-cuff 40are sufficiently flexible to allow anterior and posterior deflection ofthe distal region 45 in the sagittal plane 97 when the main-cuff isfully deflated, as shown in FIG. 21. Such deflection further facilitatesriding or tracking of the distal region 45 of the main-cuff 40 over theposterior contours of the throat 32 by allowing the distal region todeflect as necessary to conform to protrusions or recesses in theposterior surface of the throat.

The deflated main-cuff 40 further enters into its correct positionopposite the laryngeal inlet 67 without colliding with anteriorstructures such as the posterior surface of the tongue 202, epiglottis35, or arytenoids 205. Insertion of the deflated main-cuff 40 isfacilitated by forming the main-cuff 40 and attaching it to thebackplate 27 such that the seam 85 abuts the backplate, as shown inFIGS. 12, 13 and 14. As a result, when the main-cuff 40 is fullydeflated, the anterior surface of the main-cuff is uninterrupted by theseam 85, i.e., the seam is buried between the backplate 27 and thedeflated main-cuff. Accordingly, the likelihood is reduced of theanterior surface of the deflated main-cuff 40 scraping or catching onthe anatomical structures of the throat 32, such as the epiglottis 35and arytenoids 205. Further disclosure of insertion of the deflatedmain-cuff 40 through the throat 32 may be had by reference to U.S. Pat.No. 5,632,271, the entire disclosure of which is hereby incorporated byreference herein.

When the LMA-device 20 is fully inserted in the throat 32, theside-by-side airway tube 22 and external-drain tube 165 extendproximally from the tube joint 92 in contacting relation with the softpalate 195, and lie against the hard palate 192, i.e., the roof of themouth 25. The tubes 22, 165 are spaced inwardly of the sides of thethroat 32 to avoid damage to the lingual nerves. The tubes 22, 165 restlightly against the posterior aspect of the upper teeth, usually closeto parallel with the inner surface of the upper incisors, and emergefrom the mouth 25 between the teeth.

The bite-plate 176 is positioned at the emergence of the tubes 22, 165from the mouth 25 such that the bite-plate is disposed between the upperand lower teeth and the tubes. The teeth thereby directly contact thebite-plate 176, rather than the tubes 22, 165, to provide protection tothe tubes.

When the main-cuff 40 is correctly positioned, the distal orifice 123 ofthe internal-drain tube 115 contacts the upper oesophageal sphincter 207and lies posterior to the cricoid cartilage 210. The bevelled distalregion 45 of the main-cuff 40, including the distal orifice 123 of theinternal-drain tube 115, forms a wedge-shape of approximately 45 degreeswhen the main-cuff 40 is deflated. This facilitates insertion of themain-cuff 40 and backplate 27 behind the cricoid cartilage 210 becausesuch insertion requires the cricoid cartilage to be gently forcedanteriorly to allow passage of the wedge-shaped distal region 45,including the distal orifice 123, behind it. Further disclosure ofpositioning the LMA-device 20 may be had by reference to U.S. Pat. No.5,241,956, the entire disclosure of which is hereby incorporated byreference.

When the LMA-device 20 is completely inserted, the main-cuff 40 contactsthe base of the hypo-pharynx 212 with the distal region 45 being wedgedinto the upper opening of the upper oesophageal sphincter 207, aconstriction which is however much too small to permit the LMA-device 20to pass through it. Complete insertion of the LMA-device 20 is therebydetected by the operator as a resistance to insertion of the main-cuff40 into the upper oesophageal sphincter 207. The main-cuff 40 is theninflated with sufficient air, via the tube 55, to obtain a seal againstthe laryngo-pharyngeal perimeter. The LMA-device 20, when completelyinserted in the pharynx 197, lies in the sagittal plane 97.

Inflation of the main-cuff 40 causes expansion of the distal region 45enabling it to lie against and adapt to the pharynx 197 and hypo-pharynx212. Additionally, inflation of the main-cuff 40 causes the gas or fluidto flow into the space enclosed by the flexible panel 62 and backplate27, for example, via one or more ports in the main-cuff, resulting ininflation of the back-cuff 65. Inflation of the back-cuff 65 initiallycauses engagement between the flexible panel 62 and posterior surface ofthe pharynx 197. Further inflation of the back-cuff 65 urges themain-cuff 40 anteriorly to press it against the tissue surrounding thelaryngeal inlet 67. This tightens the sealing engagement between themain-cuff 40 and the tissue surrounding the laryngeal inlet 67, therebyreducing leakage between such tissue and the main-cuff. The sealingengagement is further improved by provision of the increasedanterior-posterior space between the oval portion 87 of the backplate 27and the anterior surface of the main-cuff 40, permitting accommodationof the posteriorly bulging posterior surface of the cricoid cartilage210 which is located distally relative to the laryngeal inlet 67.

If the back-cuff 65 is overinflated, the oval portion 87 may bulgeanteriorly outward resulting in anterior displacement of theinternal-drain tube 115 relative to the main-cuff 40, and loss of theadvantageously increased anterior-posterior space between the ovalportion 87 and the anterior surface of the main-cuff 40, describedabove. The anterior-posterior dimension a between the anterior tangencyof the internal-drain tube 115 and a plane containing the anteriorsurface of the main-cuff 40, shown in FIG. 8, must not decrease below aminimum level since such may result in the internal-drain tubeundesirably impinging against anatomical structures of the throat 32normally present in the laryngeal-chamber region 110. For example, ifthe main-cuff 40 is a standard adult size and is inflated to 40millimeters Hg (mercury), at a point b contained in the sagittal plane97 and located 40 millimeters distally from the distal end of theproximal region 42 of the main-cuff 40, shown in FIG. 9, the minimumanterior-posterior distance b must not approach 8 millimeters, ispreferably at least 10 millimeters and ideally at least 10.7millimeters.

The transversely arched profile, degree of hardness, and increasedanterior-posterior thickness of the distal portion of the oval portion87 are all factors chosen to offer adequate resistance to such anteriorbulging thereby limiting such resulting anterior displacement of theinternal-drain tube 115 near the distal region 45 of the main-cuff 40where the internal-drain tube is nearest to the anterior surface of themain-cuff. Fillets 160, 160 a and tethered panel 62 a, shown in FIGS. 11and 12, also limit anterior displacement of the internal-drain tube 115relative to the main-cuff 40. Anterior-posterior dimension a, shown inFIG. 8, should be maintained above a minimum amount to avoid anteriordisplacement of the arytenoids 205 which may obstruct flow of gasesthrough the larynx 37, and to avoid anterior displacement of anatomicalstructures relative to the main-cuff 40 which may reduce the tightnessof the seal between the main-cuff and the tissues surrounding thelaryngeal inlet 67. Additionally, the backplate 27 is preferablysufficiently flexible to deflect in the anterior-posterior directionduring insertion into the throat 32 to follow its contours, e.g., tobend around the soft palate 195.

The backplate 27 is reinforced because the prior LMA-devices (such as isdisclosed in U.S. Pat. No. 4,509,514) did not have a back-cuff, such asback-cuff 65. The back cuff 65 of the LMA-device 20 causes pressure tobe applied to the oval portion 87 of the backplate 27, which may causethe oval portion to herniate anteriorly. The backplate 27 must thereforebe designed to resist such herniation, preferably to pressures withinback-cuff 65 of up to 100 centimeters of water. Techniques forpreventing such herniation of the backplate 27 include arching thebackplate 27 such that it has a concavity facing anteriorly, making thebackplate of a high durometer silicone or other plastics material,thickening the backplate sufficiently to resist herniation (but not somuch that it becomes too stiff to bend easily around the back of thetongue 202), and possibly also providing the backplate with a midlinelongitudinally running groove for accurately locating adhesive to weldto it the back cuff 65. In addition, the back cuff 65 may be made of athin elastomeric sheet material capable of considerable elongation inresponse to the pressure within it, resulting in minimal herniation ofthe backplate 27.

The anteriorly facing laryngeal-chamber region 110 of the main-cuff 40is wider than the transverse distance between the edges of the laryngealinlet 67 as defined by the so-called aryepiglottic folds whichbilaterally border the laryngeal inlet thus encouraging a sealingcontact between the main-cuff and the pharyngeal tissues as well as thetissues bordering the laryngeal inlet. The main-cuff 40 is thusfunctionally a pharyngo-laryngeal mask airway forming an end-to-end sealagainst the larynx 37.

FIGS. 23 and 24 illustrate a third embodiment of the LMA-device 20 c.Parts in FIGS. 23 and 24 having corresponding parts in FIGS. 1 to 22have the same reference numeral with the addition of suffix c. Themain-cuff 40 c may have soft and yielding ridges (not shown) bilaterallydisposed on the anteriorly-facing distal region 45 c of the main-cuffwhich are suitably contoured to fill the anatomical grooves known as thepyriform fossae to increase the sealing efficacy of the main-cuff. TheLMA-device 20 c exploits the triangular cross-section of the grooves ofthe pyriform fossae which are roofed over and isolated by the anteriorsurface of the main-cuff 40 c bilaterally. The entire length of thegrooves of the pyriform fossae are covered by the main-cuff 40 c suchthat a respective cavity is defined by each groove and the contiguousportion of the anterior surface of the main-cuff. Incorporation of oneor more one-way valves 215, such as a reed or duck-bill valve, in theanterior wall of the main-cuff 40 c facing the grooves of the pyriformfossae permits the operator to evacuate residual gas from the cavitiesby anterior neck pressure so causing the low pressure in the cavities topull or draw the main-cuff anteriorly enhancing the seal. One-way valves215 may be duck-bill valves of the type sold by Accusil® Incorporated ofMerriville, Ind., U.S.A.

Attached to the interior surface of the anterior wall of the main-cuff40 c are respective cylindrical housings 217, shown in FIG. 24, eachsurrounding a respective one of the one-way valves 215. Deflation of themain-cuff 40 c draws its posterior wall toward the housings 217 andone-way valves 215, eventually causing the posterior wall to seat on theopen posterior ends of the housings 217, as illustrated by a portion ofthe posterior wall being shown in phantom line in FIG. 24 in dashedlines. Seating of the posterior wall of the main-cuff 40 on the openposterior ends of the housings 217 hermetically seals the respectiveone-way valves 215 from the remainder of the interior of the main-cuff.Each of the one-way valves 215 thereby becomes isolated from the reducedpressure inside the main-cuff 40 c. This prevents the reduced pressurewithin the main-cuff 40 c from drawing gases external of the main-cuffin the vicinity of the one-way valves 215 through the one-way valvesinto the main-cuff thereby enabling the reduced pressure inside themain-cuff to deflate it.

In an alternative embodiment (not shown), one-way valves 215 and theirassociated housings 217 may be replaced by ports or apertures, the endsof which within the main-cuff 40 c are each connected to a tube alsowithin the main-cuff. The tubes connected to the ports or aperturescommunicate via a tube or, less preferably, multiple tubes which extendthrough the wall of the main-cuff to a point outside of the main-cuff 40c such that the ports or apertures, and the tubes connected to them, areisolated from the interior of the main-cuff. A source of suction maythen applied to the tube or tubes outside of the main-cuff 40 c toevacuate residual gas from the cavities defined by each groove of thepyriform fossae and the contiguous portion of the anterior surface ofthe main-cuff.

The sealing efficacy of the main-cuff 40 may be further increased by anoptional wedge-shaped crescent (not shown) in sealing contact with theanterior surface of substantially the proximal one-half of themain-cuff.

The epiglottis 35, a leaf-like structure which normally projectsproximally and posteriorly, is supported against the anterior surface ofthe internal-drain tube 115. The internal-drain tube 115 thereby definesa stop to prevent the epiglottis 35 from interfering with communicationbetween the airway tube 22, via the airway port 30, and the laryngealinlet 67. This creates adequate space in the laryngeal-chamber region110 posterior to the epiglottis 35 for passage of gases between theairway port 30 and laryngeal inlet 67.

Such passage of gases between the airway port 30 and laryngeal inlet 67is mainly in the portion of the laryngeal-chamber region 110 lateral ofthe sagittal plane 97 and containing the airway port. If, however, theepiglottis 35 slides laterally from its propped position against theinternal-drain tube 115 into the lateral portion of thelaryngeal-chamber region 110 containing the airway port 30, gas passagebetween the airway port and laryngeal inlet in this portion of thelaryngeal-chamber region may be obstructed. If so, gases may circulatebetween the airway port 30 and laryngeal inlet 67 via the radialclearance between the internal-drain tube 115 and well 95, and throughthe portion of the laryngeal-chamber region 110 laterally of thesagittal plane 97 offset from the airway port 30. An alternativecirculation flowpath is thereby provided to permit adequate and free gascommunication between the airway tube 22 and laryngeal inlet 67, whilesimultaneously preventing obstruction to such gas flow by the epiglottis35. The contour of the laryngeal-side 81 of the backplate 27 props theinternal-drain tube 115 away from the laryngeal-side to facilitatesufficient radial clearance between the internal-drain tube 115 and well95 thereby to provide the adequate and free gas communication betweenthe airway tube 22 and laryngeal inlet 67.

The oval portion 87 of the backplate 27 has a sufficiently largeanterior-posterior depth to contain the internal-drain tube 115 suchthat the drain tube does not bear against other laryngeal structures andinterfere with gas flow.

The well 95 also provides a route for drainage of secretions from thetrachea, which may enter the laryngeal-chamber region 110 via thelaryngeal inlet 67. Such secretions normally collect in the well 95since, when the LMA-device 20 is fully installed and the patient issupine, the laryngeal-side 81 of the backplate 27 faces upward. In theabsence of the well 95, such secretions would collect between thelaryngeal-side 81 of the backplate 27 and internal-drain tube 115.

The adequately-sized well 95 is provided behind the internal-drain tube115 to allow gases or secretions to pass between the internal drain tubeand the backplate 27. This improves drainage of secretions emerging fromthe trachea 36 and improves gas exchange if there is any obstruction dueto the epiglottis 35 falling into the laryngeal-chamber region 110 closeto the distal-end 72 of the airway tube 22 adjacent to the airway port30.

Inflation of the main-cuff 40 causes expansion of the distal region 45including the anterior-facing lip 127, lateral portions 145, 147, andposterior portion 150 of the invaginated end, as shown in FIGS. 8 and14. The hermetic seal between the oblique distal orifice 123 of theinternal-drain tube 115 and the distal region 45 of the main-cuff 40obstructs communication between the oesophagus 57 and laryngeal-chamberregion 110. Accordingly, leakage, e.g., of contents from the oesophagus57 into the laryngeal-chamber region 110, and via the laryngeal inlet 67into the trachea is obstructed.

The invagination and 45 degree angulation of the distal end of themain-cuff 40 reduces the likelihood of leakage between the distalorifice 123 of the internal-drain tube 115 and the laryngeal-chamberregion 110 of the main-cuff 40 which may result from the expansion ofthe main-cuff being hampered at the narrower distal region 45 and distalend by the presence of the distal orifice. Also, the angle formed by themain-cuff 40 when deflated was sufficiently large to impede insertion ofthe LMA-device 20 to its correct location in the pharynx 197 oppositethe laryngeal inlet 67. The desired insertion characteristics areobtained by invagination by 3.5 millimeters (size 4) of the wall of themain-cuff 40 forming the anterior lip 127 of the distal orifice 123produced an increased expandable area around the distal orifice of theinternal-drain tube 115, improving the seal and, by drawing proximallyonly the anterior lip 127, sufficiently sharpening the angle of thedistal tip of the deflated main-cuff.

The side-by-side bonded adjacency of the airway tube 22 andexternal-drain tube 165 conforms to the cross-sectional shape of themouth 25 and throat 32 facilitating insertion into and displacementthrough the throat. The side-by-side adjacency of the airway tube 22 andexternal-drain tube 165 also reduces the likelihood of kinking when theybend.

After positioning the main-cuff 40 opposite the laryngeal inlet 67 asdescribed herein above, the ventilating apparatus (not shown) isactuated, as needed, to provide anesthesia gas to the trachea, via thelaryngeal inlet, through the airway tube 22.

The evacuation tube 80 has the following functions:

(i) the evacuation tube 80 allows gases to be administered to the lungsthrough the airway tube 22 under positive pressure without the risk ofinflating the stomach, via the upper oesophageal sphincter 207, sincegases escaping from the laryngeal-chamber region 110 between themain-cuff 40 and the tissues surrounding the laryngeal inlet 67 into thehypo-pharynx 212 will be ducted out through the evacuation tube insteadof being forced through the upper oesophageal sphincter 207 into theoesophagus 57, the latter of which may occur with other knownLMA-devices such as is disclosed in U.S. Pat. No. 4,509,514 which ishereby incorporated by reference herein;

(ii) conversely, if there is no evidence of gases being ducted throughthe evacuation tube 80 during positive pressure ventilation through theairway tube 22, this indicates proper positioning of the main-cuff 40with its distal end of the distal region 45 pressed into the base of thehypo-pharynx 212. The evacuation tube 80 thus provides monitoring ofcorrect placement of the LMA-device 20;

(iii) In the event of unexpected regurgitation though the upperoesophageal sphincter 207, gastric contents are likely to follow thepath of least resistance and enter into the evacuation tube 80 throughthe oblique orifice 123 rather than the larynx 37 via the laryngealinlet 67, the latter of which may occur with other known LMA-devicessuch as is disclosed in U.S. Pat. No. 4,509,514 which is herebyincorporated by reference herein; and

(iv) If desired, a suction catheter (not shown), probe for monitoringtemperature or other parameter (not shown), or endoscope (not shown) maybe inserted through the evacuation tube 80 provided the outer diameterof any such inserted device is less than the internal diameter of theevacuation tube.

An additional drain tube (not shown) may also be inserted though theairway tube 22 in a distal direction to emerge through the airway port30 adjacent to the well 95. A suction may be applied to such additionaldrain tube to remove secretions which may collect in the well 95. Thedifferent inner diameters of the airway tube 22 and external-drain tube165 facilitate their respective identifications by the operator so tofacilitate insertion into the proper tube of such additional drain-tubesor endoscope.

The internal- and external-drain tubes 115, 165 have different externalbut the same internal diameters because the external-drain tube must besoft in order to bend around the tongue 202 without exerting unduepressure on it. For example, a disadvantage of the airway tube of theLMA-device disclosed in U.S. Pat. No. 4,509,514 is that it may be toostiff. If the external-drain tube 165 is too soft, however, it may kinkunless it has a sufficient wall-thickness. The airway tube 22 must be ofmaximum internal diameter for optimal gas flow through it but of minimumoutside diameter to reduce its cross-sectional area and consequent bulk.The resulting outer diameter of the airway tube 22, about 11 millimeters(for #4), is therefore applied to the outer diameter of theexternal-drain tube 165. The tubes 22, 165 therefore have the same orsimilar outer diameter, but for different reasons.

The portion of the internal-drain tube 115 contained in thelaryngeal-chamber region 110, however, preferably also has a reducedouter diameter to prevent it from interfering with free passage of gaseswithin the laryngeal-chamber region. Additionally, the inner diameter ofthe internal-drain tube 115 is the same as the inner diameter of theexternal-drain tube 165 because if the inner diameter of theinternal-drain tube is less than the inner diameter of theexternal-drain tube, the clinician will not know if a catheter insertedthrough the external-drain tube from outside the mouth will pass throughthe internal-drain tube. If the inner diameter of the internal-draintube 115 is less than the inner diameter of the external-drain tube 165,then a catheter just able to pass through the external-drain tube (e.g.,the catheter having an outer cross-sectional area which is slightlysmaller than that of the external-drain tube) will become obstructedwhen it reaches the internal-drain tube having the narrower internalcross-section.

Conversely, if the inner diameter of the internal-drain tube 115 islarger than the inner diameter of the external-drain tube 165, then theouter diameter of the internal-drain tube must be correspondingly largerresulting in the internal-drain tube having a larger outercross-sectional area thereby occupying additional space in thelaryngeal-chamber region 110 (free space within the laryngeal-chamberregion is precious). The additional internal cross-sectional area of theinternal-drain tube 115 resulting from its larger inner diameter would,however, limited use since, for example, the gastric flow volume throughthe internal-drain tube would be limited by the smaller internalcross-sectional area of the external-drain tube 165.

Anatomical Structures

Ary-epiglottic folds—wings of tissue joining the arytenoid cartilages205 to each side of the epiglottis 35.

Arytenoid Cartilages 205—a pair of pyramid-shaped cartilages borderingthe posterior rim of the laryngeal inlet 67. Arytenoid cartilages 205are attached anteriorly to the vocal cords which they open, close,lengthen and shorten by rotation and sliding actions, pulled by thelaryngeal muscles. The most important of the arytenoid cartilages 205 isthe posterior crico-arytenoid muscle, which draws the vocal cords opento permit air to enter and leave the lungs.

Cervical vertebrae—the neck bones, of which there are seven countingfrom above downwards. The sixth vertebral body lies opposite the cricoidcartilage 210 and the distal tip of the LMA-device 20 lies between thetwo when correctly inserted.

Constrictor muscles—three cylinders of muscle stacked within each otherlike plastic cups surround the interior space of the pharynx 197 and actsequentially to squeeze swallowed food into the oesophagus 57. The lowerpharyngeal constrictor muscle is the one which mostly wraps around theinserted LMA-device 20. The lowest part of this muscle (most distalpart) forms a complete ring and defines the upper oesophageal sphincter207, also known as the crico-pharyngeus muscle.

Cricoid cartilage 210—a ring of cartilage which acts as the container orchamber of the larynx 37. Cricoid cartilage 210 is attached distally tothe trachea or wind-pipe 36. From the lateral sides of the cricoidcartilage 210, the membrane forming the vocal cords stretches upwardsand medially. Proximally, the thyroid cartilage surrounds the cricoidcartilage 210 but overlaps it on either side postero-laterally.Posteriorly, the broad flat surface (lamina) of the cricoid cartilage210 carries the paired posterior crico-arytenoid muscles, which areseparated in the mid-line by a ridge. There is normally no space betweenthe muscle-covered lamina an the posterior wall of the pharynx 197, sowhen the LMA-device 20 enters this area of the pharynx, the LMA-device20 must squeeze in between these two normally contiguous surfaces. Hencethe need to make the deflated LMA-device 20 form a suitable wedge-shapewith sufficient resilience to slip in behind (posterior to) the cricoid210. The part of the internal-drain tube 115 which is enclosed by thedistal region 45 of main-cuff 40 of the LMA-device 20 lies immediatelyposterior to the mid-line ridge on the back of the cricoid cartilage210. Were the LMA-device 20 to lie to one or other side, it mightcompress one or other of the vitally important posterior crico-arytenoidmuscles.

Cricopharingeus muscle—same as upper esophageal sphincter 207. Part ofthe inferior constrictor muscle of the pharynx 197.

Epiglottis 35—a fibro-elastic cartilage often described as leaf-shaped,whose pointed end is firmly attached to the posterior surface of thefront of the thyroid cartilage and whose lateral borders are suspendedbetween the ary-epiglottic folds, so that its free posterior surfaceprojects proximally and posteriorly. This free posterior surface actslike a shield preventing food entering the glottis but can also causeobstruction to air-flow especially when the pharyngeal space sagsinwardly as surrounding muscles weaken during anaesthesia. If the spaceavailable inside the LMA-device 20 is inadequate, the epiglottis 35potentially causes obstruction, particularly if it is large and floppyas may be the case in elderly males. The epiglottis 35 may be downfoldedover the laryngeal vestibule if the distal tip of main-cuff 40 catchesit and flips it downwards during insertion. Correct deflation andinsertion of the LMA-device 20 minimise this risk, as does a good designpermitting the optimal wedge-shape of the deflated LMA-device.

Oesophagus 57—muscular tube which is normally closed, unlike the trachea36 which lies immediately anterior to it. The muscular coat is thickenedto form the upper oesophageal sphincter 207 and lower oesophagealsphincter. Stimulating the upper oesophageal sphincter 207 excessivelyby insertion of a bulky device or inflation of the LMA-device 20 to toohigh a pressure may cause the upper oesophageal sphincter 207 and loweroesophageal sphincter to open reflexively, making regurgitation ofgastric contents more likely. Also, the esophageal muscles tend to relaxduring anaesthesia, so if there is any obstruction to inspiration, ascaused for example by closure of the glottis or a misplaced LMA-device20, the chest movement of inspiration may cause such a high negativepressure within the chest cavity that the thin-walled oesophagus 57 isliterally sucked open, encouraging fluids to be drawn up into it fromthe stomach. A correctly placed LMA-device 20 with a hole in the distalend, e.g., distal orifice 123, communicating with the oesophagus 57 mayprevent this cycle of events from occurring, since it permits air to bedrawn into the oesophagus from above.

Glottis—the constriction of the airway tube 22 which occurs in theregion of the vocal cords. The larynx 37 is the structure whichsurrounds and controls the movements and shape of the glottic opening.

Hard Palate 192—the dome shaped bony vault which arches over the uppersurface of the tongue 202. The soft palate 195 is attached to itposteriorly and it stretches down to the dental arcades anteriorly andlaterally. The anterior surface of the hard palate 192 blends with thegums and is innervated with nerves which trigger deglutition. Hence theimportance of stimulating the anterior surface of the hard palate 192when inserting the LMA-device 20, which must be designed so that whendeflated, its posterior surface forms a smooth broad sheet which impartsa soft, atraumatic feel to the surface of the hard palate 192,stimulating the acceptance of the LMA-device 20 by triggeringdeglutition reflexes rather than rejection of the LMA-device, e.g.,triggering vomiting reflexes.

Hyoid bone—a semicircular ring of bone vital to the mechanical 0.5functions of swallowing, including opening of the mouth 25. The hyoidbone lies above, i.e., proximal to, the thyroid cartilage and isattached above to the base of the tongue 202, the front of the mandibleand the base of the skull. The lower part of the hyoid bone is attachedto the chest wall, the thyroid cartilage and the pharyngeal constrictormechanism. The lateral wings of the hyoid bone press into the sides ofthe inflated main-cuff 40 of the LMA-device 20 near the proximal region42 of the main-cuff 40. The hypoglossal nerves pass near the inner endsof the hyoid bone, limiting the pressure which should be safelygenerated within the main-cuff 40 and the lateral expansion permissiblein any device inflated in this region of the pharynx 197.

Hypo-pharynx 212—the region of the pharynx 197 lying behind the larynx37, and normally a closed sack at the level of the cricoid 210. Adjacentto the base of hypo-pharynx 212 is the closed upper oesophagealsphincter 207. The hypo-pharynx 212 is surrounded by the middle andlower constrictor muscles. Anteriorly, the distal region of thehypo-pharynx 212 is bordered by the posterior surface of the cricoidcartilage 210. Also anteriorly, the proximal region of the hypo-pharynx212 is bordered by the laryngeal vestibule.

Inter-arytenoid muscle—the muscle joining the two arytenoid cartilages205 posteriorly and transversely, and proximal to the upper border ofthe cricoid cartilage 210. The inter-arytenoid muscle consists of twoparts, a straight transverse part and an “X” shaped part, both of whichenable closure of the glottis. The distal end of the bowl which definesthe posterior surface of the laryngeal-chamber region 110 of theLMA-device 20 must have adequate depth to avoid interfering with theinter-arytenoid muscle or with the arytenoid cartilages 205 which lieimmediately anterior to it. Bruising of the overlying mucosal surface iscommon with improper insertion of the LMA-device 20.

Larynx 37—the apparatus responsible for protecting the entrance to thelungs from contamination and for vocalisation. The principle advantageof the LMA-device 20 is that it permits the larynx 37 to retain thesefunctions, of which the first is the most important. Endotrachealintubation prevents effective coughing, which is an airways-cleaningmechanism vital to our survival.

Laryngeal inlet 67—the rim of tissue surrounding the vestibule of thelarynx 37, consisting of the ary-epiglottic folds laterally, the tip ofthe epiglottis 35 proximally, and the arytenoids 205 and inter-arytenoidnotch distally.

Laryngeal vestibule—a pocket of space above the vocal cords boundedlaterally by the quadrate membranes, proximally by the epiglottis 35 anddistally by the vocal cords. The distal tip of the LMA-device 20 maylodge in the laryngeal vestibule if the tip does not pass posterior tothe arytenoids 205. The laryngeal vestibule closes during swallowing,partly by the action of the ary-epiglottic muscle which acts like asphincter and partly by the elevation of the larynx 37. This closure ofthe laryngeal vestibule is observed when the LMA-device 20 is insertedprematurely.

Posterior crico-arytenoid muscle—the most important muscle of the larynx37 because it acts to separate the vocal cords. The posteriorcrico-arytenoid muscle lies as a pair of muscles on the posteriorsurface of the cricoid lamina, which is the broad posterior region ofthe cricoid cartilage 210. The distal tip of the LMA-device 20 pressesagainst the cartilaginous ridge which separates the two muscles.Excessive pressure in the main-cuff 40 might drive blood out of themuscle, depriving it of the necessary oxygen to function, though such acomplication has yet to be reported.

Pyriform fossae—gutters lying on either side of the entrance to thelarynx 37, bounded medially by the ary-epiglottic folds and laterally bythe membranes stretching between the thyroid horns and the hyoid bones.

Quadrate membrane—the side-walls of the laryngeal vestibule. Thequadrate membrane is bounded below by the rima glottidis, posteriorly bythe ary-epiglottic folds, and anteriorly by the epiglottis 35.

Rima glottidis—the space between the vocal cords.

Soft palate 195—a muscular wedge of tissue extending posteriorly fromthe posterior edge of the hard palate 192. The surfaces of the softpalate 195 converge to the mid-line posteriorly and distally to end in amid-line triangular structure known as the uvula. The soft palate 195acts like a bridge arching across the space separating the nasal cavityfrom the rest of the pharynx 197 and completely closes this gap duringswallowing. Insertion of the LMA-device 20 relies on the resistanceoffered by the oral surface of the soft palate 195 to distally guide thedistal tip of LMA-device 20. If the deflated LMA-device 20 is too rigid,or incorrectly deflated, the soft palate 195 cannot guide it downwards,thereby impeding insertion of the LMA-device 20 into the pharynx 197.

Thyroid cartilage—a shield-like structure whose lower border bilaterallyoverlaps the cricoid cartilage 210. The thyroid cartilage has twoposterior-directed horns, the lower of which articulates with the sidesof the cricoid 210, so that the whole structure can hinge on the cricoidin the manner of a visor of a helmet. This articulation produced by thecrico-thyroid muscle serves to lengthen the vocal cords. The epiglottis35 is attached to the anterior prominence of the thyroid, also known asthe “Adam's Apple”, because it projects more sharply in males.

Trachea 36—the wind-pipe, connected directly to the lower rim of thecricoid cartilage 210.

Upper esophageal sphincter 207—guards the entrance to the oesophagus 57.The upper esophageal sphincter 207 is normally closed, even when theLMA-device 20 is in place and pressed into the upper surface of theupper esophageal sphincter. The upper esophageal sphincter 207 can opento approximately 1.5.times.1.0 centimeters.

Vocal cords—folds of tissue which represent the upper free borders of amembrane arising from the cricoid 210, i.e., the crico-vocal membrane.The vocal cords vibrate, lengthen and shorten (for speech), adduct (toprevent soiling of the airway or trachea 36 and to allow coughing), andabduct (to admit air to the lungs). The crico-thyroid muscle lengthensthe vocal cords by activating the visor-like hinging action of thecrico-thyroid joint. The thyro-arytenoid muscle shortens the vocal cordsby pulling the arytenoids 205 anteriorly. The vocalis muscle thickensthe vocal cords to affect vibration frequency. The posteriorcrico-arytenoids abduct the vocal cords. The transverse arytenoids andlateral crico-arytenoids draw the arytenoids 205 together to close thevocal cords.

While the invention has been described by reference to certain preferredembodiments, it should be understood that numerous changes could be madewithin the spirit and scope of the inventive concept described.Accordingly, it is intended that the invention not be limited to thedisclosed embodiments, but that it have the full scope permitted by thelanguage of the following claims.

What is claimed is:
 1. A laryngeal mask airway device comprising: acuff, the cuff being insertable through a mouth of a patient to aninserted location within the patient, the cuff forming a seal around alaryngeal inlet of the patient when the cuff is at the insertedlocation, the cuff defining a distal end and a central aperture; anairway tube having a proximal end, a continuous airway extending fromthe proximal end of the airway tube to the central aperture of the cuff,the proximal end of the airway tube adapted to be disposed outside thepatient's mouth when the cuff is at the inserted location; and adrainage tube extending from the cuffs distal end to a location outsidethe patient's mouth when the cuff is at the inserted location, thedrainage tube defining an anterior surface, a portion of the anteriorsurface being in the central aperture, the anterior surface preventingan epiglottis of the patient from falling into the central aperturesubstantially past the drainage tube when the cuff is at the insertedlocation; wherein the drainage tube longitudinally traverses theinterior of the distal end of the cuff in sealed relation with thedistal end; and wherein the drainage tube is configured to drain gastricdischarge from an esophageal inlet area of the patient when the cuff isat the inserted location.
 2. The laryngeal mask airway device of claim 1wherein the cuff is part of a mask portion.
 3. The laryngeal mask airwaydevice of claim 2 wherein the mask portion includes a concavelaryngeal-side and a convex pharyngeal-side, the concave laryngeal-sideforming a bowl-shaped structure with a proximal end and a distal end. 4.The laryngeal mask airway device of claim 3 wherein a deepest part ofthe bowl-shaped structure is at the proximal end of the bowl-shapedstructure.
 5. The laryngeal mask airway device of claim 4 wherein thebowl-shaped structure ramps anteriorily from the proximal end of thebowl-shaped structure to the distal end of the bowl-shaped structure. 6.The laryngeal mask airway device of claim 3, wherein the distal end ofthe airway tube joins the mask portion at the proximal end of thebowl-shaped structure.
 7. The laryngeal mask airway device of claim 3wherein the drainage tube includes an interior portion and an exteriorportion, the exterior portion of the drainage tube joining the maskportion at the proximal end of the bowl-shaped structure and theinterior portion of the drainage tube spanning the bowl-shaped structurefrom the proximal end of the bowl-shaped structure to the distal end ofthe bowl-shaped structure.
 8. The laryngeal mask airway device of claim7 wherein the drainage tube contacts an interior surface of thebowl-shaped structure.
 9. The laryngeal mask airway device of claim 8wherein the interior surface of the bowl-shaped structure defines adepression, the depression being positioned below the interior portionof the drainage tube near the proximal end of the bowl-shaped structure.10. The laryngeal mask airway device of claim 1 further comprising abackplate attached to the cuff, the backplate having a concavelaryngeal-side and a convex pharyngeal-side, the concave laryngeal-sideforming a bowl-shaped structure with a proximal end and a distal end.11. A laryngeal mask airway device comprising: a mask portion includinga cuff, the mask portion being insertable through a mouth of a patientto an inserted location within the patient, the mask portion forming aseal around a laryngeal inlet of the patient when the mask portion is atthe inserted location, the mask portion defining a distal end and acentral aperture; an airway tube having a proximal end and a distal endand defining a passage extending from the proximal end to the distalend, the distal end of the airway tube joining the mask portion, acontinuous airway extending from the proximal end of the airway tube tothe central aperture of the mask portion, the proximal end of the airwaytube adapted to be disposed outside the patient's mouth when the maskportion is at the inserted location; and a drainage tube, the drainagetube including an interior portion and an exterior portion, the interiorportion extending from the mask portion's distal end through the maskportion, wherein the interior portion of the drainage tubelongitudinally traverses the interior of the distal end of the cuff insealed relation therewith, the exterior portion extending from the maskportion to a location outside the patient's mouth when the mask portionis at the inserted location, the interior portion of the drainage tubedefining an anterior surface in the central aperture, the interiorportion of the drainage tube being longer than a distance between thelocation near the mask portion's distal end and the mask portion so thatthe interior portion of the drainage tube curves substantially into anaxis defined by the distal end of the airway tube; wherein the drainagetube is configured to drain gastric discharge from an esophageal inletarea of the patient when the mask portion is at the inserted location.12. The laryngeal mask airway device of claim 11 wherein the maskportion includes a concave laryngeal-side and a convex pharyngeal-side,the concave laryngeal-side forming a bowl-shaped structure with aproximal end and a distal end.
 13. The laryngeal mask airway device ofclaim 12 wherein a deepest part of the bowl-shaped structure is at theproximal end of the bowl-shaped structure.
 14. The laryngeal mask airwaydevice of claim 13 wherein the bowl-shaped structure ramps anteriorilyfrom the proximal end of the bowl-shaped structure to the distal end ofthe bowl-shaped structure.
 15. The laryngeal mask airway device of claim12, wherein the distal end of the airway tube joins the mask portion atthe proximal end of the bowl-shaped structure.
 16. The laryngeal maskairway device of claim 12 wherein the exterior portion of the drainagetube joins the mask portion at the proximal end of the bowl-shapedstructure and the interior portion of the drainage tube spans thebowl-shaped structure from the proximal end of the bowl-shaped structureto the distal end of the bowl-shaped structure.
 17. The laryngeal maskairway device of claim 16 wherein the drainage tube contacts an interiorsurface of the bowl-shaped structure.
 18. The laryngeal mask airwaydevice of claim 17 wherein the interior surface of the bowl-shapedstructure defines a depression, the depression being positioned belowthe interior portion of the drainage tube near the proximal end of thebowl-shaped structure.
 19. The laryngeal mask airway device of claim 11further comprising a backplate attached to the cuff, the backplatehaving a concave laryngeal-side and a convex pharyngeal-side, theconcave laryngeal-side forming a bowl-shaped structure with a proximalend and a distal end.
 20. A laryngeal mask airway device comprising: acuff, the cuff being insertable through a mouth of a patient to aninserted location within the patient, the cuff forming a seal around alaryngeal inlet of the patient when the cuff is at the insertedlocation, the cuff defining a distal end and a central aperture; anairway tube having a proximal end, a continuous airway extending fromthe proximal end of the airway tube to the central aperture of the cuff,the proximal end of the airway tube adapted to be disposed outside thepatient's mouth when the cuff is at the inserted location; a drainagetube extending from the cuff's distal end to a location outside thepatient's mouth when the cuff is in the inserted location, the drainagetube defining an anterior surface, a portion of the anterior surfacebeing in the central aperture, the anterior surface preventing anepiglottis of the patient from falling into the central aperturesubstantially past the drainage tube when the cuff is at the insertedlocation, wherein the drainage tube longitudinally traverses theinterior of the distal end of the cuff in sealed relation with thedistal end; wherein the drainage tube is configured to drain gastricdischarge from an esophageal inlet area of the patient when the cuff isat the inserted location; and a biteplate, wherein the biteplate isdisposed between the upper and lower teeth of the patient when thedevice is in the inserted location within the patient.